FDA ANDA · ANDA079080
DIVALPROEX SODIUM
Sponsor: ACTAVIS LABS FL INC
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APPLICATION
ANDA079080
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-25
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DIVALPROEX SODIUMDiscontinued
DIVALPROEX SODIUM EQ 500MG VALPROIC ACID · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-10-14Labeling · Supplement 6 · standardAP
2026-10-14Labeling · Supplement 9 · standardAP
2026-10-14Labeling · Supplement 7 · standardAP
2020-10-19Labeling · Supplement 1 · standardAP
2020-10-19Labeling · Supplement 4 · standardAP
2020-10-19Labeling · Supplement 2 · standardAP
2020-10-19Labeling · Supplement 5 · standardAP
2020-10-19Labeling · Supplement 3 · standardAP
2011-02-25OriginalAP
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